Hanger Cranial Band

GUDID 00859065006003

Cranial Remolding Orthosis

HANGER NATRIONAL LABORATORIES LLC

Cranial orthosis
Primary Device ID00859065006003
NIH Device Record Keyaa367ab3-4b6e-4227-86e9-2af3b8aa9ee8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHanger Cranial Band
Version Model NumberF8210
Company DUNS079272629
Company NameHANGER NATRIONAL LABORATORIES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859065006003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVAOrthosis, Cranial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-05

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